Bitcoin Energy Use Could be Slashed Significantly


Image Credit: Rich (Flickr)


Could a Code Change Slash Cryptocurrency Energy Use?

 

Fewer and fewer people are using bitcoin for digital payments. Nevertheless, bitcoin transactions are consuming more energy than ever before – the same amount as the whole of Thailand. With a carbon footprint equivalent to the Czech Republic’s (around 114 million tonnes per year), bitcoin is cancelling out other climate wins.

The global take-up of electric vehicles, for example, is estimated to have prevented 50 million tonnes of CO2 so far. That’s less than half of bitcoin’s emissions for a single year. And the problem’s getting worse. The growth of bitcoin “mining” powered by fossil fuels is outpacing greener alternatives, causing bitcoin’s carbon footprint to swell five-fold in just two years.

 

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It was written by and represents the research-based opinions of Peter Howson, Senior Lecturer in International Development, Northumbria University, Newcastle.

 

But, according to campaign groups Greenpeace and the Environmental Working Group, all this can be easily fixed with a simple update to bitcoin’s software. Their campaign, called Change the Code Not the Climate, launched recently and calls on bitcoin software developers to switch the network from its currently wasteful system for verifying transactions to a more climate-friendly alternative.

The switch, they claim, would reduce bitcoin’s carbon footprint by 99.9%. But it’s unlikely to happen soon – and here’s why.

 

Proof of Waste to Proof of Stake?

Bitcoiners don’t trust bankers, taxmen and other meddling middlemen. Because there are no banks with bitcoin, the job of keeping the books straight is given to a global network of specialist computers. The owners of these computers compete for bookkeeping tasks in return for the transaction fees paid by network users. They also get a few newly minted bitcoins as a thank you.

This competition is known as Proof of Work (PoW) mining. It works like an ever-expanding game of hungry hippos. The more players that join the contest, the more work each hippo needs to do in order to win anything. If a new hippo with green intentions joins the game, everyone at the table has to work harder. Players powered by coal in Kazakhstan, or fossil gas in Texas, then belch out extra smog.

The higher the bitcoin price, the more the dirty hippos are prepared to waste on coal and gas until their costs for doing so are equal to their reward. And so, Proof of Work is proof of waste. And this is waste by design: Bitcoiners call this inefficiency “the feature, not the bug”.

Greenpeace hopes the bitcoin community could learn to love Proof of Stake (PoS) instead. With the network running on PoS, bitcoin’s bookkeepers would need to stake a prescribed minimum number of bitcoins as a security deposit. If they validate fraudulent transactions, they lose their stake. This disincentive keeps the network secure.

A number of blockchains, including Cardano, EOS, and TRON already use a PoS system, where token holders vote for the most qualified block producers. While bitcoin currently uses millions of mining computers, these PoS networks usually maintain an assembly of around 20 machines using a comparably minuscule amount of energy, taking turns to receive bookkeeping rights.

 

Code Blockers

For bitcoin, coding these changes would be straightforward. Greenpeace claims that only 30 people – the largest mining outfits, exchanges like Coinbase and Binance, and code developers – would need to agree the switch to PoS.

But this ignores the fact that everyone would need to run the upgraded software. On average, to successfully mine bitcoin once per week requires shelling out around US$1.8 million (£1.4 million) on hardware. Most miners are protective of these investments and conservative when it comes to amending the software code that underwrites their winnings.

For this reason, Chris Bendiksen, a commentator at the cryptocurrency website CoinShares, puts the chance of Bitcoin ever moving to PoS at 0%. “There is no appetite among Bitcoiners to destroy the security of the protocol by making such a move”, he says.

Bitcoin is no stranger to coding stalemates. An amendment to fix intermittent congestion issues and stabilize transaction fees was proposed in 2016. Despite being a relatively simple fix, the change split the bitcoin community, with the vast majority continuing to support the slower, more expensive status quo.

Even if some users were prepared to ditch PoW, the original bitcoin network would continue in some form. This PoW version would keep the name, branding, super-rich disciples, and polluting PoW miners. The PoS offshoot could end up as just another disappointing experiment.

Another PoW heavyweight network, Ethereum, has been promising a shift to PoS since birth. But this migration has remained just around the corner for several years.

Starting a PoS network from scratch is another option. But there is already a BitcoinPoS cryptocurrency. Aside from an early flurry of interest, it’s attracted few supporters.

 

Tackling Crypto Greenwashing

Many Bitcoiners scoffed at the Greenpeace campaign. After all, much of the funding for this marketing mission comes from billionaire venture capitalist Chris Larsen, co-founder of rival cryptocurrency Ripple.

Larsen’s Ripple was also an original member of the UN-backed Crypto Climate Accord, an organization convened in April 2021 to promote more sustainable cryptocurrency trading. In response, prominent bitcoin advocates established the Bitcoin Mining Council – a public relations group aiming to “defend bitcoin against uninformed and hostile energy critics,” like Larsen.

Some argue governments in Europe and North America should follow China’s lead and ban PoW mining.

Retaliatory campaigns from bitcoin advocates are ramping up, and their greenwashing appears to be winning. The European Parliament recently rejected a bill to ban PoW mining across the EU. The UK government also fears an exodus of crypto trading talent to other financial centers. Research I have led suggests that effective regulation of bitcoin will not come from charity appeals. A globally coordinated ban, led by governments, is likely to prove the most effective solution.

 

Suggested Reading



Crypto Mining Gives Mothballed Fossil Fuel Plants New Life



Small-Cap Names in a Big Crypto Market





The Advantages of Microcap Equities for Investors



Why the Metaverse is Attracting Traditional Professions

 

Stay up to date. Follow us:

 

Tonix Pharmaceuticals Announces Extension of Sponsored Research Agreement with Kansas State University to Develop Live-Virus Vaccine Against COVID-19



Tonix Pharmaceuticals Announces Extension of Sponsored Research Agreement with Kansas State University to Develop Live-Virus Vaccine Against COVID-19

Research, News, and Market Data on Tonix Pharmaceuticals

 

TNX-2300, a Live Virus Vaccine Based on a Bovine Parainfluenza Virus Vector, in Development to Protect Against COVID-19

Co-Expression of the CD40-Ligand Will be Tested to Direct Immune Response

CHATHAM, N.J., April 05, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced a new preclinical research agreement with Kansas State University (K-State) to extend the research being performed under its original agreement. Tonix and K-State are working together to develop a vaccine candidate for the prevention of COVID-19 that utilizes a novel live virus vaccine vector platform, bovine parainfluenza virus, and also to test the effect of co-expression of the CD40-ligand, also known as CD154 or 5c8 antigen, to stimulate T cell immunity.

“Vaccines based on live replicating viruses trigger the immune system by direct stimulation of T cells, with the potential to elicit strong, long-lasting and durable immunity,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “There are currently well over 300 potential COVID-19 vaccines in various stages of development1, but relatively very few utilize live replicating viral platforms. TNX-2300* is a live replicating virus vaccine designed to elicit T cell immunity.”

Dr. Lederman continued, “Modern live virus vaccines in development for COVID-19 use a vector system to present SARS-CoV-2 protein antigens. K-State is studying bovine parainfluenza virus as the vector. A traditional live virus vaccine approach would use a weakened version of SARS-CoV-2, but SARS-CoV-2 contains genes that weaken the immune response by thwarting innate immunity. In the first completed phase of the research project, K-State showed that vaccinating hamsters with bovine parainfluenza virus expressing SARS-CoV-2 spike protein elicited antibody responses to the SARS-CoV-2 spike protein. Our goal in utilizing bovine parainfluenza virus as a live virus vaccine vector is to develop a COVID-19 vaccine that is well tolerated, produces durable immunity, prevents forward transmission and can be rapidly and broadly deployed.”

Under the extended research agreement, K-State will continue to advance preclinical development of a live replicating virus vaccine to protect against COVID-19 based on bovine parainfluenza virus and also to test the effect of co-expression of the CD40-ligand.

Attenuated bovine parainfluenza virus has previously been shown to be an effective antigen delivery vector in humans2-7. Notably and most importantly, following extensive testing in non-human primates, the attenuated BPI3V was shown to be well tolerated, infectious, immunogenic, and stable in infants and children3,6. The vector is well suited for mucosal immunization using a nasal atomizer, but it can also be delivered parenterally. The technology also includes a molecular stimulant called CD40-ligand, which triggers strong immunity, including T cell responses. TNX-2300 is designed to potentially stimulate immunity against the SARS-CoV-2 spike protein. The research is being directed by Dr. Waithaka Mwangi, Kansas State University, Department of Diagnostic Medicine/Pathobiology, who is the inventor of the new technology. In addition, K-State has granted Tonix an option for an exclusive license for the clinical and commercial use of K-State’s intellectual property associated with coronavirus vaccines under this relationship.

*TNX-2300 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.

1World Health Organizationhttps://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccinesCOVID-19 – Landscape of novel coronavirus candidate vaccine development worldwide, March 2022.
2Liang, B., et al., J. Virol. 2016. 90:10022.
3Karron, R. A., et al., Vaccine. 2012. 30:3975.
4Haller, A. A., et al., J. Gen Virol. 2003. 84:2153.
5Schmidt, A. C., et al., J. Virol. 2001. 75:4594.
6Karron, R. A., et al., J. Infec. Diseases. 1995. 171:1107.
7Haller, A. A., et al., J. Virol. 2000. 74:11626.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, an antiviral to treat COVID-19, and a potential treatment for Long COVID. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-COVID condition. Tonix expects to initiate a Phase 2 study in Long COVID in the first half of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study expected to start in the first half of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the first half of 2022.

1TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
2TNX-2900 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
3TNX-801 is a live horsepox virus vaccine for percutaneous administration in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.
4TNX-1840 and TNX-1850 are live horsepox virus vaccines for percutaneous administration, in development to protect against COVID-19. TNX-1840 and TNX-1850 are designed to express the SARS-CoV-2 spike protein from the omicron and BA.2 variants, respectively. TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. 
5TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
6TNX-102 SL is an investigational new drug and has not been approved for any indication.
7TNX-1300 is an investigational new biologic and has not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the development of TNX-2300; the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
olipriya.das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Musk Refiles with SEC Changing Status to Active Investor in Twitter



Twitter Gets a New Board Member Who Instantly Causes Stock to Rocket

 

Elon Musk, known to be one of the most innovative CEOs of this generation, has been causing the SEC to become more innovative just to keep him from violating
disclosure rules
and other regulations. Some of his more public SEC problems are with what he
posts on Twitter
as the CEO of Tesla. On Monday, he filed the wrong regulatory paperwork, and filed it late. The report disclosed a huge stake in Twitter. On Tuesday, he refiled.

 

Background

On Monday (March 4), Elon Musk disclosed that he bought a 9.2% stake in the social media platform Twitter. This made him the company’s largest shareholder and set off a rally in its shares of more than 27%. US securities law requires that within ten days of acquiring 5% or more of a company, a report must be filed reporting the event. The filing said that March 14, 2022, is the date of the event that required the disclosure. Under this timeline, March 24 would have been the day the ownership report should have been filed. The penalty for this is determined per violation and could amount to $207,183, according to Urska Velikonja, a law professor at Georgetown University Law Center.

Based on the 27% increase in Twitter’s stock price, on $3 billion invested, the civil penalty wouldn’t be felt at all. But there is concern the SEC could look into market manipulation allegations regarding the Twitter stock purchase, and seek harsher sanctions in a previous and ongoing SEC problem regarding a sale he made in Tesla (TSLA) stock to raise money to pay
$11 billion in taxes
.

Edit Button on SEC Reports

Do-over. Elon Musk has taken the step to refile his disclosure, placing himself in the category of an active investor. The old filing (form 13G classified him as a passive investor). The new disclosure (form 13D) categorizes Musk as an active investor. It shows he had been acquiring Twitter shares almost daily between January 31 and April 1. The price range was $32.80 to $40.30. Twitter closed Tuesday at $50.98.

Board Seat

Elon Musk has been involved in such diverse companies as Paypal (PYPL), SpaceX, Tesla (TSLA), The Boring Company, and even the Dogecoin
Foundation.
No doubt, he recognizes the power of social media or micro-blogging. He is also, in his own words a, “free speech absolutist.” So, for Musk to be in the position of being the largest shareholder and have a seat in the boardroom as the company decides the best road to take for its shareholders, is considered a positive for Twitter. The company has lost significant share price this year as users have become disheartened with management’s policies regarding Tweet rules and behind the scene elevation of some discussions over others.

Take-Away

On March 25, Musk tweeted a poll: “Free speech is essential to a functioning democracy. Do you believe Twitter rigorously adheres to this principle?” The next day he Tweeted he was giving “serious thought” to building a new social media platform.  This week he moved in that direction.

His public concern is that Twitter is not an open forum. The serial entrepreneur is likely to put his mark on the company as a board member and as a significant shareholder. Investors have reacted positively to the news.

 

Suggested Reading



Elon Reminds Jeff Bezos that He’s Pulling Away



Elon Musk Weighs in on Unrealized Capital Gains Tax Idea





Musk Boosts DOGE Once Again



Dogecoin Group Works to Give Currency Greater Purpose

 

Sources

https://www.nasdaq.com/articles/analysis-teslas-musk-may-add-to-sec-ire-with-late-report-about-twitter-stake

www.finance.yahoo.com/news/musk-refiles-disclosure-show-221958940.html

 

Stay up to date. Follow us:

 

Tokens.com (SMURF) – Building Momentum for 2022 and Beyond

Wednesday, April 06, 2022

Tokens.com (SMURF)
Building Momentum for 2022 and Beyond

Tokens.com Corp is a Proof-of-Stake technology company that provides investors with a secure way to gain exposure to staking rewards and cryptocurrencies. It provides investors with exposure to the digital assets that power Decentralized Finance and Non-Fungible Tokens, without the burden of buying, managing, and securing digital assets themselves. The company creates value for its investors through earning Staking yields and the appreciation of its digital asset inventory, all achieved through environmentally friendly technology.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    4Q21 Results. Tokens.com reported 4Q21 revenue of $326,185, a sequential decline from the third quarter’s $448,976, due to a decline in the value of the crypto assets. We had estimated revenue of $640,000. Higher one-time operating expenses drove an operating loss of $3.0 million in the quarter, with a net loss for the quarter of $3.7 million, or a loss of $0.04 per share. We had projected net income of $25,000, or breakeven per share.

    Poised for 2022.  Today, Tokens.com has three Web 3.0 verticals: purchase and staking, through PoS technology, of tokens; the Metaverse Group, which is focused on building a virtually integrated digital real estate business; and Hulk Labs, which is focused on holding NFT assets and investing in crypto based games that have a token return attached to them …


This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

 

Cypress Development (CYDVF)(CYP) – Clayton Valley Project to Source Lithium from Nevada Claystone

Wednesday, April 06, 2022

Cypress Development (CYDVF)(CYP)
Clayton Valley Project to Source Lithium from Nevada Claystone

Cypress Development Corp is a Canadian exploration company. It is principally engaged in the acquisition, exploration, and evaluation of resource properties. The company holds an interest in Clayton Valley Lithium Project and Gunman Zinc / Silver Project which are located in Nevada. The company operates through the single segment being The Acquisition and exploration of mineral properties.

Mark Reichman, Senior Research Analyst of Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    Initiating coverage. Cypress Development Corp. is advancing its 100%-owned Clayton Valley Lithium Project encompassing 6,500 acres in Esmeralda County near Silver Peak, Nevada. Cypress intends to mine Nevada claystone, produce a high-grade lithium concentrate solution and apply a licensed lithium extraction process based on ion-exchange to produce lithium carbonate or hydroxide. Clayton Valley offers several competitive advantages, including a large land package in a mining friendly state, an existing lithium carbonate equivalent resource base, well-developed infrastructure, direct lithium extraction technology, a leased facility permitted for pilot testing, and secured water rights.

    Significant existing mineral resource.  A preliminary feasibility study, amended in March 2021, highlighted 1.304 billion tonnes of indicated resources, averaging 905 parts per million (ppm) lithium, including probable reserves of 213 million tonnes of probable reserves averaging 1,129 parts per million (ppm) lithium, or 1.28 million tonnes of lithium carbonate equivalent (LCE). The study affirmed …


This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

 

Tonix Pharmaceuticals Announces IND Clearance for TNX-102 SL as a Potential Treatment for Long COVID Syndrome, Also Known as Post-Acute Sequelae of COVID-19 (PASC)



Tonix Pharmaceuticals Announces IND Clearance for TNX-102 SL as a Potential Treatment for Long COVID Syndrome, Also Known as Post-Acute Sequelae of COVID-19 (PASC)

Research, News, and Market Data on Tonix Pharmaceuticals

 

Phase 2 Clinical Trial of TNX-102 SL for the Treatment of Long COVID Expected to Start Second Quarter 2022

Long COVID Afflicts More Than 30% of Patients Following Infection with SARS-CoV-2, the Virus that Causes COVID-19, and is Expected to be a Global Health Burden

CHATHAM, N.J., April 06, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support a Phase 2 clinical trial with TNX-102 SL1 as a potential treatment for a subset of patients with Long COVID Syndrome (Long COVID) whose symptoms overlap with fibromyalgia. Long COVID is now known officially as Post-Acute Sequelae of COVID-19 (PASC2).

“We are excited to have received the FDA’s IND clearance to begin clinical trials of TNX-102 SL for the treatment of Long COVID,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Over 30% of people who recover from COVID-19 continue to experience a constellation of symptoms long past the time that they have recovered from acute COVID-19 illness3-4. The symptoms of Long COVID, which can include fatigue, multi-site pain, sleep disturbances, fevers, shortness of breath, cognitive impairment, gastrointestinal symptoms, anxiety, and depression, can persist for many months and can range from mild to incapacitating5. Our study will focus on testing TNX-102 SL in the treatment of patients with multi-site pain associated with Long COVID. This group of patients have symptoms that overlap with other chronic pain conditions, which as a group have been termed, ‘chronic overlapping pain conditions.’6,7 This type of pain syndrome is increasingly recognized as nociplastic pain,8 and the underlying mechanism as ‘central sensitization.’9 Fibromyalgia is considered one of the chronic overlapping pain conditions and our experience with TNX-102 SL in fibromyalgia is the motivation for undertaking the development of TNX-102 SL in patients with Long COVID whose symptoms overlap with fibromyalgia.”

About the Phase 2 Study

This Phase 2 study will be a double-blind randomized, placebo-controlled 14-week trial to evaluate the safety and efficacy of sublingual TNX-102 SL 5.6 mg daily at bedtime in the treatment of patients with multi-site pain associated with Long COVID. The trial will be conducted at approximately 30 sites to enroll approximately 470 patients (235 per arm) who will be randomized in a 1:1 ratio to treatment with TNX-102 SL or placebo tablets. The primary efficacy endpoint will be Change from Baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. An interim analysis is expected to be completed after the first 50% of enrolled patients have completed the study for the purpose of possible sample size re-estimation.

About Long COVID or Post-Acute Sequelae of SARS-CoV-2 (PASC)

Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develop a chronic syndrome called Long COVID. These individuals experience a constellation of disabling symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 infection from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, multi-site pain, fevers, shortness of breath, cognitive impairment described as “brain fog” or memory disturbance, gastrointestinal symptoms, anxiety, and depression. Long COVID can persist for many months and can range in severity from mild to incapacitating. Several cohort studies have reported that persistence of symptoms following SARS-CoV-2 infection occurs in more than 30% of patients.3-5 While typically associated with moderate or severe COVID-19, Long COVID can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. Patients with Long COVID are sometimes referred to as “long-haulers”. Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.10-13 In response to the urgent need for therapies that address Long COVID, Congress awarded $1.15 billion to the National Institutes of Health to study Long COVID in December 2020.14 While the vaccines available in the U.S. through either FDA approval or under Emergency Use Authorization have been shown to prevent acute COVID, their ability to prevent Long COVID is unknown. There is currently no approved drug for the treatment of Long COVID.

1 TNX-102 SL is an investigational new drug and has not been approved for any indication.
2 Feb. 24, 2021 – White House COVID-19 Response Team press briefing; Feb 25, 2021 – policy brief from the World Health Organization on long COVID.
3 Logue JK, et al. (2021) “Sequelae in Adults at 6 Months After COVID-19 Infection”. JAMA Netw Open. ;4(2):e210830. doi:10.1001/jamanetworkopen.2021.0830
4 Carfì, A et al.. (2020) “Persistent symptoms in patients after acute COVID-19.” JAMA 324.6: 603-605.
5 Nalbandian, Ani, et al. (2021) “Post-acute COVID-19 syndrome.” Nature Medicine27(4): 601-615.
6 Maixner W, et al.. (2016) “Overlapping Chronic Pain Conditions: Implications for Diagnosis and Classification”. J Pain. 17(9 Suppl):T93-T107.
7 Veasley C, et al. (2015): Impact of chronic overlapping pain conditions on public health and the urgent need for safe and effective treatment: 2015 analysis and policy recommendations. Chronic Pain Research Alliance. http://www.chronicpainresearch. org/public/CPRA_WhitePaper_2015-FINAL-Digital.pdf. Accessed July 26, 2021.
8 Trouvin AP, Perrot S. (2019) “New concepts of pain”. Best Pract Res Clin Rheumatol. 33(3):101415.
9 Nijs J, George SZ, Clauw DJ, et al. (2021) “Central sensitisation in chronic pain conditions: latest discoveries and their potential for precision medicine”. The Lancet Rheumatology. 3(5):e383-e392. doi:10.1016/s2665-9913(21)00032-1
10 Briggs, A, and Vassall, A. (2021) “Count the cost of disability caused by COVID-19.” Nature 593(7860): 502-505.
11 Nittas V, et al. (2022) “Long COVID Through a Public Health Lens: An Umbrella Review.” Public Health Rev. 43:1604501. Published 2022 Mar 15. doi:10.3389/phrs.2022.1604501
12 Davis, HE., et al. (2021) “Characterizing long COVID in an international cohort: 7 months of symptoms and their impact.” EClinicalMedicine 38: 101019.
13 Martin C, et al. (2021) “A model framework for projecting the prevalence and impact of Long-COVID in the UK.” PLoS One. 16(12):e0260843. Published 2021 Dec 2. doi:10.1371/journal.pone.0260843
14 The NIH provision of Title III Health and Human Services, Division M–Coronavirus Response and Relief Supplemental Appropriations Act, 2021, of H.R. 133, The Consolidated Appropriations Act of 2021. The bill was enacted into law on 27 December 2020, becoming Public Law 116-260.

About TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the serotonin-5-HT2A, ?1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development as a daily bedtime treatment for Long COVID, fibromyalgia, PTSD, alcohol use disorder, and agitation in Alzheimer’s disease. The U.S. Patent and Trademark Office (USPTO) has issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in these patents are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID that overlaps with fibromyalgia, a chronic post-COVID condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study expected to start in the second quarter of 2022. Finally, TNX-13006 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022.

1 TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
2 TNX-2900 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
3 TNX-801 is a live horsepox virus vaccine for percutaneous administration in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.
4 TNX-1840 and TNX-1850 are live horsepox virus vaccines for percutaneous administration, in development to protect against COVID-19. TNX-1840 and TNX-1850 are designed to express the SARS-CoV-2 spike protein from the omicron and BA.2 variants, respectively. TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. 
5 TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
6 TNX-1300 is an investigational new biologic and has not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the development of TNX-102 SL, failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
olipriya.das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Release – Tonix Pharmaceuticals Announces IND Clearance for TNX-102 SL



Tonix Pharmaceuticals Announces IND Clearance for TNX-102 SL as a Potential Treatment for Long COVID Syndrome, Also Known as Post-Acute Sequelae of COVID-19 (PASC)

Research, News, and Market Data on Tonix Pharmaceuticals

 

Phase 2 Clinical Trial of TNX-102 SL for the Treatment of Long COVID Expected to Start Second Quarter 2022

Long COVID Afflicts More Than 30% of Patients Following Infection with SARS-CoV-2, the Virus that Causes COVID-19, and is Expected to be a Global Health Burden

CHATHAM, N.J., April 06, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support a Phase 2 clinical trial with TNX-102 SL1 as a potential treatment for a subset of patients with Long COVID Syndrome (Long COVID) whose symptoms overlap with fibromyalgia. Long COVID is now known officially as Post-Acute Sequelae of COVID-19 (PASC2).

“We are excited to have received the FDA’s IND clearance to begin clinical trials of TNX-102 SL for the treatment of Long COVID,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Over 30% of people who recover from COVID-19 continue to experience a constellation of symptoms long past the time that they have recovered from acute COVID-19 illness3-4. The symptoms of Long COVID, which can include fatigue, multi-site pain, sleep disturbances, fevers, shortness of breath, cognitive impairment, gastrointestinal symptoms, anxiety, and depression, can persist for many months and can range from mild to incapacitating5. Our study will focus on testing TNX-102 SL in the treatment of patients with multi-site pain associated with Long COVID. This group of patients have symptoms that overlap with other chronic pain conditions, which as a group have been termed, ‘chronic overlapping pain conditions.’6,7 This type of pain syndrome is increasingly recognized as nociplastic pain,8 and the underlying mechanism as ‘central sensitization.’9 Fibromyalgia is considered one of the chronic overlapping pain conditions and our experience with TNX-102 SL in fibromyalgia is the motivation for undertaking the development of TNX-102 SL in patients with Long COVID whose symptoms overlap with fibromyalgia.”

About the Phase 2 Study

This Phase 2 study will be a double-blind randomized, placebo-controlled 14-week trial to evaluate the safety and efficacy of sublingual TNX-102 SL 5.6 mg daily at bedtime in the treatment of patients with multi-site pain associated with Long COVID. The trial will be conducted at approximately 30 sites to enroll approximately 470 patients (235 per arm) who will be randomized in a 1:1 ratio to treatment with TNX-102 SL or placebo tablets. The primary efficacy endpoint will be Change from Baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. An interim analysis is expected to be completed after the first 50% of enrolled patients have completed the study for the purpose of possible sample size re-estimation.

About Long COVID or Post-Acute Sequelae of SARS-CoV-2 (PASC)

Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develop a chronic syndrome called Long COVID. These individuals experience a constellation of disabling symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 infection from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, multi-site pain, fevers, shortness of breath, cognitive impairment described as “brain fog” or memory disturbance, gastrointestinal symptoms, anxiety, and depression. Long COVID can persist for many months and can range in severity from mild to incapacitating. Several cohort studies have reported that persistence of symptoms following SARS-CoV-2 infection occurs in more than 30% of patients.3-5 While typically associated with moderate or severe COVID-19, Long COVID can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. Patients with Long COVID are sometimes referred to as “long-haulers”. Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.10-13 In response to the urgent need for therapies that address Long COVID, Congress awarded $1.15 billion to the National Institutes of Health to study Long COVID in December 2020.14 While the vaccines available in the U.S. through either FDA approval or under Emergency Use Authorization have been shown to prevent acute COVID, their ability to prevent Long COVID is unknown. There is currently no approved drug for the treatment of Long COVID.

1 TNX-102 SL is an investigational new drug and has not been approved for any indication.
2 Feb. 24, 2021 – White House COVID-19 Response Team press briefing; Feb 25, 2021 – policy brief from the World Health Organization on long COVID.
3 Logue JK, et al. (2021) “Sequelae in Adults at 6 Months After COVID-19 Infection”. JAMA Netw Open. ;4(2):e210830. doi:10.1001/jamanetworkopen.2021.0830
4 Carfì, A et al.. (2020) “Persistent symptoms in patients after acute COVID-19.” JAMA 324.6: 603-605.
5 Nalbandian, Ani, et al. (2021) “Post-acute COVID-19 syndrome.” Nature Medicine27(4): 601-615.
6 Maixner W, et al.. (2016) “Overlapping Chronic Pain Conditions: Implications for Diagnosis and Classification”. J Pain. 17(9 Suppl):T93-T107.
7 Veasley C, et al. (2015): Impact of chronic overlapping pain conditions on public health and the urgent need for safe and effective treatment: 2015 analysis and policy recommendations. Chronic Pain Research Alliance. http://www.chronicpainresearch. org/public/CPRA_WhitePaper_2015-FINAL-Digital.pdf. Accessed July 26, 2021.
8 Trouvin AP, Perrot S. (2019) “New concepts of pain”. Best Pract Res Clin Rheumatol. 33(3):101415.
9 Nijs J, George SZ, Clauw DJ, et al. (2021) “Central sensitisation in chronic pain conditions: latest discoveries and their potential for precision medicine”. The Lancet Rheumatology. 3(5):e383-e392. doi:10.1016/s2665-9913(21)00032-1
10 Briggs, A, and Vassall, A. (2021) “Count the cost of disability caused by COVID-19.” Nature 593(7860): 502-505.
11 Nittas V, et al. (2022) “Long COVID Through a Public Health Lens: An Umbrella Review.” Public Health Rev. 43:1604501. Published 2022 Mar 15. doi:10.3389/phrs.2022.1604501
12 Davis, HE., et al. (2021) “Characterizing long COVID in an international cohort: 7 months of symptoms and their impact.” EClinicalMedicine 38: 101019.
13 Martin C, et al. (2021) “A model framework for projecting the prevalence and impact of Long-COVID in the UK.” PLoS One. 16(12):e0260843. Published 2021 Dec 2. doi:10.1371/journal.pone.0260843
14 The NIH provision of Title III Health and Human Services, Division M–Coronavirus Response and Relief Supplemental Appropriations Act, 2021, of H.R. 133, The Consolidated Appropriations Act of 2021. The bill was enacted into law on 27 December 2020, becoming Public Law 116-260.

About TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the serotonin-5-HT2A, ?1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development as a daily bedtime treatment for Long COVID, fibromyalgia, PTSD, alcohol use disorder, and agitation in Alzheimer’s disease. The U.S. Patent and Trademark Office (USPTO) has issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in these patents are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID that overlaps with fibromyalgia, a chronic post-COVID condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study expected to start in the second quarter of 2022. Finally, TNX-13006 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022.

1 TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
2 TNX-2900 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
3 TNX-801 is a live horsepox virus vaccine for percutaneous administration in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.
4 TNX-1840 and TNX-1850 are live horsepox virus vaccines for percutaneous administration, in development to protect against COVID-19. TNX-1840 and TNX-1850 are designed to express the SARS-CoV-2 spike protein from the omicron and BA.2 variants, respectively. TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. 
5 TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
6 TNX-1300 is an investigational new biologic and has not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the development of TNX-102 SL, failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
olipriya.das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Release – Tonix Pharmaceuticals Announces Extension of Sponsored Research Agreement with Kansas State University



Tonix Pharmaceuticals Announces Extension of Sponsored Research Agreement with Kansas State University to Develop Live-Virus Vaccine Against COVID-19

Research, News, and Market Data on Tonix Pharmaceuticals

 

TNX-2300, a Live Virus Vaccine Based on a Bovine Parainfluenza Virus Vector, in Development to Protect Against COVID-19

Co-Expression of the CD40-Ligand Will be Tested to Direct Immune Response

CHATHAM, N.J., April 05, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced a new preclinical research agreement with Kansas State University (K-State) to extend the research being performed under its original agreement. Tonix and K-State are working together to develop a vaccine candidate for the prevention of COVID-19 that utilizes a novel live virus vaccine vector platform, bovine parainfluenza virus, and also to test the effect of co-expression of the CD40-ligand, also known as CD154 or 5c8 antigen, to stimulate T cell immunity.

“Vaccines based on live replicating viruses trigger the immune system by direct stimulation of T cells, with the potential to elicit strong, long-lasting and durable immunity,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “There are currently well over 300 potential COVID-19 vaccines in various stages of development1, but relatively very few utilize live replicating viral platforms. TNX-2300* is a live replicating virus vaccine designed to elicit T cell immunity.”

Dr. Lederman continued, “Modern live virus vaccines in development for COVID-19 use a vector system to present SARS-CoV-2 protein antigens. K-State is studying bovine parainfluenza virus as the vector. A traditional live virus vaccine approach would use a weakened version of SARS-CoV-2, but SARS-CoV-2 contains genes that weaken the immune response by thwarting innate immunity. In the first completed phase of the research project, K-State showed that vaccinating hamsters with bovine parainfluenza virus expressing SARS-CoV-2 spike protein elicited antibody responses to the SARS-CoV-2 spike protein. Our goal in utilizing bovine parainfluenza virus as a live virus vaccine vector is to develop a COVID-19 vaccine that is well tolerated, produces durable immunity, prevents forward transmission and can be rapidly and broadly deployed.”

Under the extended research agreement, K-State will continue to advance preclinical development of a live replicating virus vaccine to protect against COVID-19 based on bovine parainfluenza virus and also to test the effect of co-expression of the CD40-ligand.

Attenuated bovine parainfluenza virus has previously been shown to be an effective antigen delivery vector in humans2-7. Notably and most importantly, following extensive testing in non-human primates, the attenuated BPI3V was shown to be well tolerated, infectious, immunogenic, and stable in infants and children3,6. The vector is well suited for mucosal immunization using a nasal atomizer, but it can also be delivered parenterally. The technology also includes a molecular stimulant called CD40-ligand, which triggers strong immunity, including T cell responses. TNX-2300 is designed to potentially stimulate immunity against the SARS-CoV-2 spike protein. The research is being directed by Dr. Waithaka Mwangi, Kansas State University, Department of Diagnostic Medicine/Pathobiology, who is the inventor of the new technology. In addition, K-State has granted Tonix an option for an exclusive license for the clinical and commercial use of K-State’s intellectual property associated with coronavirus vaccines under this relationship.

*TNX-2300 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.

1World Health Organizationhttps://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccinesCOVID-19 – Landscape of novel coronavirus candidate vaccine development worldwide, March 2022.
2Liang, B., et al., J. Virol. 2016. 90:10022.
3Karron, R. A., et al., Vaccine. 2012. 30:3975.
4Haller, A. A., et al., J. Gen Virol. 2003. 84:2153.
5Schmidt, A. C., et al., J. Virol. 2001. 75:4594.
6Karron, R. A., et al., J. Infec. Diseases. 1995. 171:1107.
7Haller, A. A., et al., J. Virol. 2000. 74:11626.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, an antiviral to treat COVID-19, and a potential treatment for Long COVID. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-COVID condition. Tonix expects to initiate a Phase 2 study in Long COVID in the first half of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study expected to start in the first half of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the first half of 2022.

1TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
2TNX-2900 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
3TNX-801 is a live horsepox virus vaccine for percutaneous administration in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.
4TNX-1840 and TNX-1850 are live horsepox virus vaccines for percutaneous administration, in development to protect against COVID-19. TNX-1840 and TNX-1850 are designed to express the SARS-CoV-2 spike protein from the omicron and BA.2 variants, respectively. TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. 
5TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
6TNX-102 SL is an investigational new drug and has not been approved for any indication.
7TNX-1300 is an investigational new biologic and has not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the development of TNX-2300; the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
olipriya.das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Beasley Broadcast Group (BBGI) Scheduled to Present at NobleCon18 Investor Conference


Beasley CFO Marie Tedesco provides a preview of their upcoming presentation at NobleCon18

NobleCon18 – Noble Capital Markets 18th Annual Small and Microcap Investor Conference – April 19-21, 2022 – Hard Rock, Hollywood, FL 100+ Public Company Presentations | Scheduled Breakouts | Panel Presentations | High-Profile Keynotes | Educational Sessions | Receptions & Networking Events

Free Registration Available – More Info


Research News and Advanced Market Data on BBGI


NobleCon18 Presenting Companies

About Beasley

Beasley Media Group (BMG), LLC, a subsidiary of Beasley Broadcast Group, Inc., is a multiplatform media company providing advertising and digital marketing solutions across the United States. BMG owns 62 radio properties located in large and medium markets across the country, as well as offers capabilities in audio technology, esports, podcasting, ecommerce and events. Founded in 1961, nearly 41% of Beasley radio properties are located in the nation’s top 50 markets such as Philadelphia, Boston, Detroit, Las Vegas, New Jersey, West Palm Beach, Boston and Atlanta. The remaining stations are primarily in vibrant regional centers like Central North Carolina, Northeast Georgia and Southeast Florida.

Smart For Life (SMFL) Scheduled to Present at NobleCon18 Investor Conference


Smart For Life Executive Chairman AJ Cervantes provides a preview of their upcoming presentation at NobleCon18

NobleCon18 – Noble Capital Markets 18th Annual Small and Microcap Investor Conference – April 19-21, 2022 – Hard Rock, Hollywood, FL 100+ Public Company Presentations | Scheduled Breakouts | Panel Presentations | High-Profile Keynotes | Educational Sessions | Receptions & Networking Events

Free Registration Available – More Info


News and Advanced Market Data on SMFL


NobleCon18 Presenting Companies

About Smart for Life

Smart for Life, Inc. (Nasdaq: SMFL) is engaged in the development, marketing, manufacturing, acquisition, operation and sale of a broad spectrum of nutritional and related products with an emphasis on health and wellness. Structured as a global holding company, the Company is executing a buy-and-build strategy with serial accretive acquisitions creating a vertically integrated company with an objective of aggregating companies generating a minimum of $300 million in revenues within the next thirty-six months. To drive growth and earnings, Smart for Life is developing proprietary products as well as acquiring other profitable companies, encompassing brands, manufacturing and distribution channels. The Company currently operates four subsidiaries including Doctors Scientific Organica, Nexus Offers, Bonne Santé Natural Manufacturing and GSP Nutrition. For more information about Smart for Life, please visit: www.smartforlifecorp.com.

HMNC Brain Health Scheduled to Present at NobleCon18 Investor Conference


HMNC Brain Health CFO Nir Naor provides a preview of their upcoming presentation at NobleCon18

NobleCon18 – Noble Capital Markets 18th Annual Small and Microcap Investor Conference – April 19-21, 2022 – Hard Rock, Hollywood, FL 100+ Public Company Presentations | Scheduled Breakouts | Panel Presentations | High-Profile Keynotes | Educational Sessions | Receptions & Networking Events

Free Registration Available – More Info


Learn more about HMNC


NobleCon18 Presenting Companies

About HMNC Brain Health

HMNC Brain Health is a disruptive clinical stage biopharma company pioneering Precision Psychiatry, powered by its AI Platform, and focusing on Treatment-Resistant Depression (TRD) and Major Depressive Disorder (MDD). HMNC Brain Health uses its AI Platform, combining Psychiatry, Genomics, and Analytics, to develop innovative therapies for mental health disorders.

Indonesia Energy Corp (INDO) – Rating upgraded to Market Perform following sharp price decline

Wednesday, April 06, 2022

Indonesia Energy Corp (INDO)
Rating upgraded to Market Perform following sharp price decline

Indonesia Energy Corp Ltd is an oil and gas exploration and production company focused on Indonesia. It holds two oil and gas assets through its subsidiaries in Indonesia: one producing block (the Kruh Block) and one exploration block (the Citarum Block). The Kruh Block is located to the northwest of Pendopo, Pali, South Sumatra. The Citarum Block is located to the south of Jakarta.

Michael Heim, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    We are raising our rating on the shares of INDO. The shares of INDO took on a MEME stock character beginning in the third week of February rising from a price near $4.50 per share to as high as $87 per share in a mere two weeks. During that two week period, there were no significant company developments although it should be noted that oil prices rose from $92/bbl to $109/bbl. Since peaking on March 7th, the shares have steadily declined, recently settling at a price near $20 per share.

    We downgraded the stock to Underperform from Outperform on March 8th after the stock shot through our $15 price target.  Since that time, oil price have been relatively flat and the only company development was the filing of a preliminary prospectus (3/8/22) for the resale of up to 9.1 million shares of stock including 8.3 million by an unnamed shareholder. As such, we continue to believe a fair …


This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

 

Defense Metals (DFMTF)(DEFN:CA) – Keeping the Momentum Going

Wednesday, April 06, 2022

Defense Metals (DFMTF)(DEFN:CA)
Keeping the Momentum Going

Noble Capital Markets research on Defense Metals Corp. is published under ticker symbols DFMTF and DEFN:CA. The price target for DFMTF is in USD and the price target for DEFN:CA is in CAD. Defense Metals Corp. is a mineral exploration and development company focused on the acquisition, exploration and development of mineral deposits containing metals and elements commonly used in the electric power market, defense industry, national security sector and in the production of green energy technologies, such as, rare earths magnets used in wind turbines and in permanent magnet motors for electric vehicles. Defense Metals owns 100% of the Wicheeda Rare Earth Element Property located near Prince George, British Columbia, Canada. Defense Metals Corp. trades in Canada under the symbol “DEFN” on the TSX Venture Exchange, in the United States, under “DFMTF” on the OTCQB and in Germany on the Frankfurt Exchange under “35D”.

Mark Reichman, Senior Research Analyst of Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    Equity funding. Defense Metals raised gross proceeds in the amount of $4.6 million from the private placement of 6.3 million flow-through (FT) common shares at a price of C$0.35 per FT share and ~9.0 million units at a price of C$0.26 per unit. Each unit consists of one common share and one common share purchase warrant which may be exercised at a price of C$0.40 for a period of 24 months. Defense Metals may accelerate the expiry of the warrants under certain conditions. Our model had assumed a C$5.0 million equity private placement.

    Upcoming drill program.  The proceeds will be used for the exploration and development of the company’s Wicheeda Rare Earth Element Project. Defense Metals expects to commence a 5,300-meter infill drilling program in May 2022 to expand and upgrade resources which will be incorporated, along with results from the 2021 drill program, into a preliminary feasibility study (PFS) to be released during the …


This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.